PINNACLE3 SMARTARC
FDA 510(k) clearance K090808 · decided 2009-04-03
Clearance details
- K-number
- K090808
- Device name
- PINNACLE3 SMARTARC
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-25
- Decision date
- 2009-04-03
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- MUJ
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Fitchburg, WI, US
- Third-party review
- Yes
- Expedited review
- No
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